BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      AB 1069


                                                                      Page  1





          ASSEMBLY THIRD READING


          AB  
          1069 (Gordon)


          As Amended  May 6, 2015


          Majority vote


           ----------------------------------------------------------------- 
          |Committee       |Votes |Ayes                |Noes                |
          |                |      |                    |                    |
          |                |      |                    |                    |
          |----------------+------+--------------------+--------------------|
          |Health          |17-0  |Bonta, Maienschein, |                    |
          |                |      |Bonilla, Burke,     |                    |
          |                |      |Chávez, Chiu,       |                    |
          |                |      |Gomez, Gonzalez,    |                    |
          |                |      |Lackey, Patterson,  |                    |
          |                |      |Ridley-Thomas,      |                    |
          |                |      |Rodriguez,          |                    |
          |                |      |Santiago,           |                    |
          |                |      |Steinorth,          |                    |
          |                |      |Thurmond, Waldron,  |                    |
          |                |      |Wood                |                    |
          |                |      |                    |                    |
          |                |      |                    |                    |
           ----------------------------------------------------------------- 


          SUMMARY:  Modifies the handling and repackaging requirements for  
          donated pharmaceuticals at voluntary, county-operated prescription  
          drug collection and distribution programs.  










                                                                      AB 1069


                                                                      Page  2





          EXISTING LAW:  


          1)Establishes a voluntary, county-operated prescription drug  
            collection and distribution program (Program) to distribute  
            surplus medications to persons in need of financial assistance  
            to ensure access to necessary pharmaceutical therapies.


          2)Establishes the California Board of Pharmacy (BOP) to regulate  
            the practice of pharmacy and enforce the pharmacy law.   
            Authorizes the BOP to adopt rules and regulations pertaining to  
            establishments wherein any drug or device is compounded,  
            prepared, furnished, or dispensed. 


          FISCAL EFFECT:  None


          COMMENTS:  The author states that this bill is necessary to  
          improve current and future Programs by making two necessary  
          operational changes which will allow for the packaging of  
          medications in advance and allow for transfers to non-adjacent  
          counties.  When the Program was initially enacted, it was one of  
          the first in the country and had few examples to draw from.  The  
          Program has been operational for almost five years and has  
          provided enough medications to fill over 30,000 prescriptions.   
          According to the author, it has become evident that improvements  
          are needed to help streamline the program's operations, encourage  
          additional counties to participate, and help more low-income  
          Californians get the medicine that they need to stay healthy.  


          Background.  The Program was created by SB 798 (Simitian), Chapter  
          444, Statutes of 2005, and SB 1329 (Simitian), Chapter 709,  
          Statutes of 2012, which authorize counties to establish a system  
          to facilitate the collection and distribution of surplus unused  
          medications to medically indigent persons.  To date, two counties  
          in California (Santa Clara and San Mateo) have established a  








                                                                      AB 1069


                                                                      Page  3





          Program through local ordinance, although Santa Clara is the only  
          county currently operating a Program. 


          Supporting Initiatives to Redistribute Unused Medicine (SIRUM),  
          the sponsor of this bill, is a tax-exempt nonprofit organization  
          that connects safety-net clinics with unexpired, unopened donated  
          drugs from suppliers, pharmacies, and health facilities.  SIRUM  
          works with Santa Clara County through their Program.  SIRUM has  
          reported that over 150 participating health facilities currently  
          donate eligible medication.  An October 2013 California Healthline  
          report stated that, to date, SIRUM had administered the  
          redistribution of 444,380 units of medicine worth about $1.5  
          million wholesale. 


          Similar Programs in Other States.  According to the National  
          Conference of State Legislatures, as of January 2015, at least 38  
          states and Guam have enacted laws and programs which are similar  
          to the Program a county may establish under current California  
          law.  While many other state programs exist at the state level or  
          as part of a statewide effort, California is unique in that a  
          Program is established at the county level.  


          Support.  SIRUM, sponsor of this bill, states that this bill will  
          increase access to necessary, and in many cases life-sustaining,  
          prescription drugs to medically indigent Californians while at the  
          same time reducing the environmental impact of pharmaceutical  
          waste.  SIRUM states that with shrinking budgets for the  
          healthcare safety net and rising healthcare costs for all  
          Californians, enacting this bill would allow California to  
          maximize quality patient care by reducing the financial burden of  
          pharmaceutical acquisitions and promote environmentally  
          sustainable healthcare practices.  The Santa Clara County Board of  
          Supervisors states that improving this program would encourage  
          more counties to consider implementation of a drug collection and  
          distribution program.  









                                                                      AB 1069


                                                                      Page  4






          Opposition.  The BOP opposes this bill because it would create  
          conflicts between state and federal law.  Regulation of drug  
          distribution is complex, with a myriad of state and federal laws  
          designed to ensure the safety and efficacy of prescription drugs.   
          BOP states that they understand the author's intent to address the  
          needs of indigent patients to secure access to medications;  
          however, this bill in its current form eliminates existing patient  
          protections established in state and federal law and, if  
          improperly done, could harm patients.




          Analysis Prepared by:                                               
                          Dharia McGrew / HEALTH / (916) 319-2097  FN:  
          0000357